Hemiplegic Shoulder PainESWT-HSPNCT07485192
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain
A study testing Conventional therapy group, suprascapular nerve block and Extracorporeal Shock Wave Therapy in people with Hemiplegic Shoulder Pain, run by Kars State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) with conventional treatment for hemiplegic shoulder pain. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Conventional therapy group, suprascapular nerve block and Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hemorrhagic or ischemic stroke at least 3 months prior to enrollment.
- Patients with shoulder pain of at least 5 cm on the 10-cm Visual Analog Scale (VAS) following hemiplegia.
- Patients aged 45-70 years.
- Patients with partial tear of the supraspinatus muscle/tendon confirmed by ultrasonographic evaluation.
Who cannot join
- Patients with limited cooperation.
- Patients who received local anesthetic or corticosteroid injection to the shoulder region within the last 3 months.
- Patients with a history of surgery or radiotherapy in the shoulder region.
- Patients with pre-existing shoulder pain prior to the diagnosis of stroke.
- Patients with a cardiac pacemaker.
- Patients with malignancy or signs of acute inflammation in the treatment area.
- Patients with coagulation disorders or an INR ≥ 4.
- Patients with vascular conditions such as deep vein thrombosis, phlebitis, varicose veins, or arterial disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir
About this study
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) with conventional treatment for hemiplegic shoulder pain. A total of 67 patients aged 45-70 years, treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were randomly assigned to three groups. The first group (n=24) received conventional treatment, the second group (n=22) received conventional treatment plus one session of ultrasound-guided suprascapular nerve block, and the third group (n=21) received conventional treatment plus ESWT applied for 2 weeks, 4 days per week at 12 Hz and 2-3 bars. All groups were evaluated clinically and ultrasonographically before treatment, at 1 month, and at 3 months. Pain intensity was assessed using the visual analog scale, upper extremity motor function with the Fugl-Meyer Motor Scale, and supraspinatus muscle tear size via ultrasound.
Read the detailed description
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) when added to conventional treatment in patients with hemiplegic shoulder pain.
A total of 67 patients aged 45 to 70 years who were treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were included in the study. Participants were randomly assigned into three groups. The first group (n = 24) received conventional treatment alone. The second group (n = 22) received conventional treatment combined with a single session of ultrasound-guided suprascapular nerve block (SSNB). The third group (n = 21) received conventional treatment combined with extracorporeal shock wave therapy (ESWT), applied for two weeks, four days per week, at a frequency of 12 Hz and an intensity of 2 to 3 bars.
All participants were evaluated clinically and ultrasonographically at baseline, at one month, and at three months. Pain intensity was assessed using the Visual Analog Scale (VAS). Upper extremity motor function was evaluated using the Fugl-Meyer Motor Scale (FMMS). Supraspinatus muscle tear size was measured using ultrasonography.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Conventional therapy group, suprascapular nerve block, Extracorporeal Shock Wave Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy groupOther
Conventional treatment including transcutaneous electrical nerve stimulation, hot pack therapy for 4 weeks, and joint range of motion, stretching, and progressive resistive exercises performed 5 days per week for 12 weeks.
suprascapular nerve blockProcedure or surgery
A single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program.
Extracorporeal Shock Wave TherapyDevice
Extracorporeal shock wave therapy applied at 12 Hz frequency and 2-3 bars pressure, 4 days per week for 2 weeks, in addition to the conventional therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Participants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises Receives: Other: Conventional therapy group |
| Suprascapular Nerve Block plus Conventional Treatment | Experimental | Participants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol. Receives: Procedure: suprascapular nerve block |
| ESWT plus Conventional Treatment | Experimental | Participants received extracorporeal shock wave therapy in addition to the conventional treatment protocol. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale will be used to assess the intensity of pain reported by participants. The scale consists of a 10-cm horizontal line anchored by two extremes: 0 = no pain and 10 = worst imaginable pain. Participants will mark the point on the line that best represents their pain intensity. The score will be determined by measuring the distance (in centimeters) from the "no pain" anchor to the participant's mark, with higher scores indicating greater pain intensity.
Measured: Baseline, 1 month, and 3 months after treatment initiation.
Secondary outcomes (2)
Shoulder range of motion
Maximum passive shoulder flexion, abduction, internal rotation, and external rotation, as well as the range of motion at pain onset, were measured using a goniometer while the patient was in the supine position. Measurements were recorded in degrees, and higher values indicate greater joint range of motion.
Measured: Baseline, 1 month, and 3 months after treatment initiation.
Presence of supraspinatus tendon tear
The presence of a supraspinatus tendon tear was evaluated using ultrasonography with a branded ultrasound device. Imaging was performed by an experienced clinician.
Measured: Baseline, 1 month, and 3 months after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
- Investigators
- özge özpolat bulut, Study director, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485192
- Sponsor's protocol ID
- 2023.02.49
- Acronym
- ESWT-HSP
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SH, Ha KW, Kim YH, Seol PH, Kwak HJ, Park SW, Ryu BJ. Effect of Radial Extracorporeal Shock Wave Therapy on Hemiplegic Shoulder Pain Syndrome. Ann Rehabil Med. 2016 Jun;40(3):509-19. doi: 10.5535/arm.2016.40.3.509. Epub 2016 Jun 29.
PubMed 27446789
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT07485192
- Acronym / sponsor ID
- ESWT-HSP / 2023.02.49
- Conditions
- Hemiplegic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) with conventional treatment for hemiplegic shoulder pain. A total of 67 patients aged 45-70 years, treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were randomly assigned to three groups. The first group (n=24) received conventional treatment, the second group (n=22) received conventional treatment plus one session of ultrasound-guided suprascapular nerve block, and the third group (n=21) received conventional treatment plus ESWT applied for 2 weeks, 4 days per week at 12 Hz and 2-3 bars. All groups were evaluated clinically and ultrasonographically before treatment, at 1 month, and at 3 months. Pain intensity was assessed using the visual analog scale, upper extremity motor function with the Fugl-Meyer Motor Scale, and supraspinatus muscle tear size via ultrasound.
Detailed description
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) when added to conventional treatment in patients with hemiplegic shoulder pain.
A total of 67 patients aged 45 to 70 years who were treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were included in the study. Participants were randomly assigned into three groups. The first group (n = 24) received conventional treatment alone. The second group (n = 22) received conventional treatment combined with a single session of ultrasound-guided suprascapular nerve block (SSNB). The third group (n = 21) received conventional treatment combined with extracorporeal shock wave therapy (ESWT), applied for two weeks, four days per week, at a frequency of 12 Hz and an intensity of 2 to 3 bars.
All participants were evaluated clinically and ultrasonographically at baseline, at one month, and at three months. Pain intensity was assessed using the Visual Analog Scale (VAS). Upper extremity motor function was evaluated using the Fugl-Meyer Motor Scale (FMMS). Supraspinatus muscle tear size was measured using ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Other: Conventional therapy groupParticipants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises |
| Suprascapular Nerve Block plus Conventional Treatment | Experimental | Procedure: suprascapular nerve blockParticipants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol. |
| ESWT plus Conventional Treatment | Experimental | Device: Extracorporeal Shock Wave TherapyParticipants received extracorporeal shock wave therapy in addition to the conventional treatment protocol. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with hemorrhagic or ischemic stroke at least 3 months prior to enrollment.
- Patients with shoulder pain of at least 5 cm on the 10-cm Visual Analog Scale (VAS) following hemiplegia.
- Patients aged 45-70 years.
- Patients with partial tear of the supraspinatus muscle/tendon confirmed by ultrasonographic evaluation.
Key exclusion criteria (8 listed)
- Patients with limited cooperation.
- Patients who received local anesthetic or corticosteroid injection to the shoulder region within the last 3 months.
- Patients with a history of surgery or radiotherapy in the shoulder region.
- Patients with pre-existing shoulder pain prior to the diagnosis of stroke.
- Patients with a cardiac pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapy groupConventional treatment including transcutaneous electrical nerve stimulation, hot pack therapy for 4 weeks, and joint range of motion, stretching, and progressive resistive exercises performed 5 days per week for 12 weeks. | Other | Conventional Treatment |
| suprascapular nerve blockA single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program. | Procedure or surgery | Suprascapular Nerve Block plus Conventional Treatment |
| Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy applied at 12 Hz frequency and 2-3 bars pressure, 4 days per week for 2 weeks, in addition to the conventional therapy program. | Device | ESWT plus Conventional Treatment |
Primary outcome
Visual Analog Scale
Time frame: Baseline, 1 month, and 3 months after treatment initiation.
The Visual Analog Scale will be used to assess the intensity of pain reported by participants. The scale consists of a 10-cm horizontal line anchored by two extremes: 0 = no pain and 10 = worst imaginable pain. Participants will mark the point on the line that best represents their pain intensity. The score will be determined by measuring the distance (in centimeters) from the "no pain" anchor to the participant's mark, with higher scores indicating greater pain intensity.
2 secondary outcomes
Shoulder range of motion
Time frame: Baseline, 1 month, and 3 months after treatment initiation.
Presence of supraspinatus tendon tear
Time frame: Baseline, 1 month, and 3 months after treatment initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 27446789Kim SH, Ha KW, Kim YH, Seol PH, Kwak HJ, Park SW, Ryu BJ. Effect of Radial Extracorporeal Shock Wave Therapy on Hemiplegic Shoulder Pain Syndrome. Ann Rehabil Med. 2016 Jun;40(3):509-19. doi: 10.5535/arm.2016.40.3.509. Epub 2016 Jun 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
özge özpolat bulut study director
Kanuni Sultan Süleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy group, suprascapular nerve block and Extracorporeal Shock Wave Therapy in people with Hemiplegic Shoulder Pain, run by Kars State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, 1 month, and 3 months after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07485192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.